BLOCK-OUT SPACER 8514

GUDID 00893202000233

BLOCK-OUT SPACER

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00893202000233
• NIH Device Record Key: 05de64cb-ac84-4c5a-a8db-0aede70b4107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLOCK-OUT SPACER
• Version Model Number: 8514
• Catalog Number: 8514
• Company DUNS: 433815198
• Company Name: SWEDEN & MARTINA SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844.862.7846
• Email: info.us@sweden-martina.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893202000233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142242

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00893202000233]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-08-05

Devices Manufactured by SWEDEN & MARTINA SPA

• D7701814943 - SPARE CAST. SLEEVE FOR: 2024-10-18 SPARE CAST. SLEEVE FOR T-CONNECT
• D7701814983 - SPARE CAST. SLEEVE FOR: 2024-10-18 SPARE CAST. SLEEVE FOR T-CONNECT, RIPOSIZ., LARGE
• D7701815013 - SPARE CAST. SLEEVE FOR: 2024-10-18 SPARE CAST. SLEEVE FOR T-CONNECT, RIPOSIZ., SMALL
• D7702474203 - T-CONNECT FOR SINGLE CROWN: 2024-10-17 T-CONNECT FOR SINGLE CROWN A/SH D. 3,30 H.6 MM, H.1 MM
• D7702474233 - T-CONNECT FOR SINGLE CROWN: 2024-10-17 T-CONNECT FOR SINGLE CROWN A/SH D. 3,30 H.6 MM, H.2 MM
• D7702474263 - T-CONNECT FOR SINGLE CROWN: 2024-10-17 T-CONNECT FOR SINGLE CROWN A/SH D. 3,30 H.6 MM, H.3 MM
• D7702474283 - T-CONNECT FOR IMPLANTS BRIDGES: 2024-10-17 T-CONNECT FOR IMPLANTS BRIDGES A/SH D. 3,30 H.6 MM, H.1 MM
• D7702474293 - T-CONNECT FOR IMPLANTS BRIDGES: 2024-10-17 T-CONNECT FOR IMPLANTS BRIDGES A/SH D. 3,30 H.6 MM, H.2 MM